Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 062921

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DOXORUBICIN HYDROCHLORIDE (DOXORUBICIN HYDROCHLORIDE)
10MG/VIAL
Marketing Status: Prescription

Active Ingredient: DOXORUBICIN HYDROCHLORIDE
Proprietary Name: DOXORUBICIN HYDROCHLORIDE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 10MG/VIAL
Reference Listed Drug: No
Reference Standard: Yes
TE Code: 
Application Number: A062921
Product Number: 001
Approval Date: Mar 17, 1989
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

DOXORUBICIN HYDROCHLORIDE (DOXORUBICIN HYDROCHLORIDE)
20MG/VIAL
Marketing Status: Prescription

Active Ingredient: DOXORUBICIN HYDROCHLORIDE
Proprietary Name: DOXORUBICIN HYDROCHLORIDE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 20MG/VIAL
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AP
Application Number: A062921
Product Number: 002
Approval Date: Mar 17, 1989
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

DOXORUBICIN HYDROCHLORIDE (DOXORUBICIN HYDROCHLORIDE)
50MG/VIAL
Marketing Status: Prescription

Active Ingredient: DOXORUBICIN HYDROCHLORIDE
Proprietary Name: DOXORUBICIN HYDROCHLORIDE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 50MG/VIAL
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AP
Application Number: A062921
Product Number: 003
Approval Date: Mar 17, 1989
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information